FDA Label for Hemorrhoid Relief

View Indications, Usage & Precautions

Hemorrhoid Relief Product Label

The following document was submitted to the FDA by the labeler of this product Rite Aid Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredients (in each suppository)                                  PurposeCocoa Butter 85.5%........................................................................ ProtectantPhenylephrine HCL 0.25%............................................................... Vasoconstrictor

Otc - Purpose



Active ingredients (in each suppository)                                  PurposeCocoa Butter 85.5%........................................................................ ProtectantPhenylephrine HCL 0.25%............................................................... Vasoconstrictor________________________________________________________________________________________Uses temporarily - Shrinks hemorrhoidal tissues - relieves itching, burning and discomfort associated with hemorrhoids

Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage



Uses - shrinks hemorrhoidal tissues - relieves itching, burning and discomfort associated with hemorrhoids

Warnings



Warnings For rectal use only____________________________________________________Ask a doctor before use if you have - heart disease - high blood pressure- thyroid disease - diabetes - difficulty in urination due to enlargement of the prostate gland _____________________________________________________Ask a doctor or pharmacist before use if you are - presently taking a prescription drug for high blood pressure or depression______________________________________________________Stop use and ask a doctor if- bleeding occurs - condition gets worse or does not improve within 7 days______________________________________________________If pregnant or breastfeeding, ask a health professional before use_______________________________________________________________Keep out of reach of children. If swallowed, getmedical help or contact a Poison Control Centerright away______________________________________________________

Dosage & Administration



Directions- Adults - if possible, clean the affected area by patting or blotting with an appropriate cleansing pad- gently dry by patting or blotting with toilet tissue or a soft cloth before insertion of this product- detach one suppository from strip - remove wrapper before inserting into the rectum - hold suppositorywith rounded end up and carefully peel film slowly and evenly down both sides to expose the suppository- insert one suppository into rectum up to 4 times daily especially at night and morning or after each bowel movementChildren under 12 years of age: ask a doctor________________________________________________________________________________________Other information - store at room temperature but not over 89 degrees F (32 degrees C)

Inactive Ingredient



Inactive Ingredients starch, shark liver oil, methylparaben, propylparaben

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